Prothena Corporation plc, a clinical stage biotechnology company, focuses on the discovery, development and commercialization of antibodies for the treatment of diseases that involve protein misfolding or cell adhesion. The company focuses on therapeutic monoclonal antibodies directed specifically to disease causing proteins. Research and Development Pipeline The company’s research and development pipeline includes three therapeutic antibody programs that it intends to advance: NEOD001 for the potential treatment of AL and AA amyloidosis; PRX002 for the potential treatment of Parkinson’s disease and other related synucleinopathies; and PRX003 for the potential treatment of inflammatory diseases and cancers. NEOD001 for Amyloidosis NEOD001 is a monoclonal antibody that specifically targets the amyloid that accumulates in both AL and AA forms of amyloidosis. NEOD001 was granted orphan drug designation for the treatment of AL and AA amyloidosis by the United States Food and Drug Administration (FDA) in 2012 and for the treatment of AL amyloidosis by the European Medicines Agency in 2013. An Investigational New Drug application, or IND, for NEOD001 in systemic amyloidosis (AL and AA forms of amyloidosis) was filed and accepted by the FDA in 2012. The company has initiated a Phase 1 clinical trial for NEOD001 with the first successful patient dosed in April 2013. PRX002 for Parkinson’s Disease In 2013, the company entered into a license, development, and commercialization agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively ‘Roche’) to develop and commercialize certain antibodies that target alpha-synuclein, including PRX002. Together, the company and Roche intend to develop PRX002 as a disease-modifying treatment for Parkinson’s disease and potentially other synucleinopathies. PRX003 for Inflammatory Diseases and Cancers The company develops PRX003, a monoclonal antibody targeting melanoma cell adhesion molecule (MCAM) for the potential treatment of inflammatory diseases and cancers. The company’s research in the area of cell adhesion has uncovered unique insights into MCAM function, allowing the company to develop specific and novel antibodies that block MCAM’s VELCRO-like function as potential therapeutics to prevent disease causing cells from spreading into tissue. Strategy Main elements of the company’s strategy are as follows: continue to discover antibodies directed against novel targets involved in protein misfolding or cell adhesion; quickly translate its research discoveries into clinical development; establish early clinical proof of concept with its therapeutic antibodies; strategically collaborate or out-license select programs; highly utilize external talent and resources; collaborate with scientific and clinical experts in disease areas of interest; and evaluate commercialization strategies on a product-by-product basis in order to maximize the value of its product candidates or future potential products. Research and Development The company’s research and development expenses totaled $26.1 million in 2013. Patents and Intellectual Property Rights In connection with a program targeting AL and AA amyloid for the potential treatment of amyloidosis, the company or its affiliates own U.S. Patent No. 7,928,203, which is a composition of matter patent and expires in 2029; U.S. Patent No. 8,124,081, which is a method of treatment patent and expires in 2020; U.S. Patent No. 8,268,973, which is a composition of matter patent that expires in 2028; and U.S. Patent No. 8,404,815, which is a composition of matter patent that expires in 2028. In addition, the company or its affiliates jointly own with the University of Tennessee Research Foundation, or the University of Tennessee, issued patents in New Zealand and South Africa, and has exclusively licensed the University of Tennessee’s joint ownership interest in these patents. In connection with a program targeting alpha-synuclein, the company or its affiliates own U.S. Patent No. 8,609,820, which is a composition of matter patent that expires in 2032. In addition, the company or its affiliates jointly own with the Regents of the University of California, or the University of California, U.S. Patent Nos. 7,919,088, 8,092,801, 8,147,833 and 8,506,959, which are method of treatment patents that expire in 2025, 2029, 2027 and 2028, respectively. The company has licensed the University of California’s joint ownership interest in these patents. In connection with program targeting synuclein for the potential treatment of Parkinson’s disease and other synucleinopathies, the company or its affiliates hold an exclusive, royalty-free license from Elan Corporation Limited (Elan) and certain affiliates of Elan to U.S. Patent No. 7,910,333, which is a composition of matter patent that expires in 2024, and the company or its affiliates own or hold exclusive, royalty-free licenses from Elan and certain of its affiliates. History The company is a public limited company formed under the laws of Ireland.
prothena corp plc (PRTA:NASDAQ GS)
Phone: 353 1 902 3519
Fax: 353 1 902 3510www.prothena.com
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